PURPOSE: The placebo response rate in randomized controlled trials (RCTs) in ulcerative colitis (UC) varies from 0 to 76%. The aims of this study were to quantify the pooled placebo response rate and identify the factors affecting it. METHODS: We performed a meta-analysis of 110 RCTs carried out between 1955 and 2005 and published in English. Regression analysis was used to identify factors significantly modifying placebo response. RESULTS: The pooled placebo remission rate was 23% (95%CI: 18.4-28%) and the pooled placebo improvement rate was 32.1% (95%CI: 28.1-36.3%). Multivariate analysis showed that the country where the study was performed (P = 0.025 for placebo remission and P = 0.0083 for placebo response rates) significantly influenced the placebo remission and response rates. CONCLUSION: Placebo remission and response rates in RCTs of UC are highly variable and are significantly influenced by the country in which the RCT is performed.
PURPOSE: The placebo response rate in randomized controlled trials (RCTs) in ulcerative colitis (UC) varies from 0 to 76%. The aims of this study were to quantify the pooled placebo response rate and identify the factors affecting it. METHODS: We performed a meta-analysis of 110 RCTs carried out between 1955 and 2005 and published in English. Regression analysis was used to identify factors significantly modifying placebo response. RESULTS: The pooled placebo remission rate was 23% (95%CI: 18.4-28%) and the pooled placebo improvement rate was 32.1% (95%CI: 28.1-36.3%). Multivariate analysis showed that the country where the study was performed (P = 0.025 for placebo remission and P = 0.0083 for placebo response rates) significantly influenced the placebo remission and response rates. CONCLUSION: Placebo remission and response rates in RCTs of UC are highly variable and are significantly influenced by the country in which the RCT is performed.
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Authors: Antonio Tursi; Giovanni Brandimarte; Alfredo Papa; Andrea Giglio; Walter Elisei; Gian Marco Giorgetti; Giacomo Forti; Sergio Morini; Cesare Hassan; Maria Antonietta Pistoia; Maria Ester Modeo; Stefano Rodino'; Teresa D'Amico; Ladislava Sebkova; Natale Sacca'; Emilio Di Giulio; Francesco Luzza; Maria Imeneo; Tiziana Larussa; Salvatore Di Rosa; Vito Annese; Silvio Danese; Antonio Gasbarrini Journal: Am J Gastroenterol Date: 2010-06-01 Impact factor: 10.864